Thyroid Nodule Diagnosis via Immune Cell Quantification
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Solution Overview
Problem
Current diagnostic methods for thyroid cancer, particularly in conditions like Hashimoto's Thyroiditis and follicular lesion of undetermined significance, lack accuracy, leading to unnecessary surgeries and suboptimal diagnosis rates due to the insufficient predictive value of existing genetic testing methods.
Innovation Solution
A method involving fine needle aspiration (FNA) to collect tissue samples from thyroid nodules, analyzing lymphocytes for double negative T cells, macrophages, and NK cells, and using flow cytometry and cytokine assays to determine the likelihood of thyroid cancer, with thresholds of double negative T cell content indicating cancerous or benign nodules.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If commercially available genetic testing is used to diagnose indeterminate thyroid nodules, then diagnosis can be obtained, but the positive predictive value is only 40-50%, leading to suboptimal diagnosis accuracy and unnecessary surgeries
Solution Approach 1:
The patent changes the diagnostic parameters from tumor gene sequencing alone to a multi-parameter approach including immune cell populations (double negative T cells, macrophages, NK cells), cytokines, and chemokines. This parameter expansion increases diagnostic accuracy by capturing the tumor microenvironment's immunological state, which complements genetic information and enables more precise risk stratification of thyroid nodules
Solution Approach 2:
The diagnostic method combines multiple types of biological markers into a composite diagnostic profile: genetic mutations (BRAF, RAS, RET/PTC), immune cell populations (particularly double negative T cells exceeding 15%), and inflammatory mediators (cytokines and chemokines). This composite approach integrates different aspects of tumor biology and host response, achieving superior diagnostic accuracy compared to any single marker type
2Reliability
If high-resolution ultrasonography and FNA biopsy are used to detect thyroid nodules, then nodule detection is achieved, but controversy remains regarding optimal diagnosis approach and management
Solution Approach 1:
The patent segments the diagnostic process into distinct analytical components: (1) nodule characterization via ultrasonography, (2) cellular analysis via FNA including tumor cells and immune cells, (3) genetic testing for tumor mutations, (4) immunological profiling for immune cell populations and cytokines, and (5) integrated risk stratification. This segmentation allows each component to be optimized independently while maintaining overall diagnostic reliability and procedural simplicity
3Loss of information
If tumor gene sequencing is performed on indeterminate thyroid nodules, then genetic information is obtained, but it is insufficient to predict thyroid malignancy with high accuracy
Solution Approach 1:
The patent merges tumor-intrinsic genetic information with tumor-extrinsic immunological information from the microenvironment. By combining gene sequencing results with immune cell population data (especially double negative T cells), cytokine profiles, and chemokine levels, the method creates a comprehensive predictive model that captures both the tumor's genetic drivers and the host's immune response, thereby completing the predictive information gap left by gene sequencing alone
Data Source
AI summary
Methods for extracting and analyzing a sample, and methods for predicting or diagnosing thyroid cancers and disorders, are described.